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Dosing Information

TRELSTAR must be administered under the supervision of a physician.

TRELSTAR is administered by a single intramuscular injection in either buttock. Dosing schedule depends on the product strength selected (Table 1). The lyophilized microgranules are to be reconstituted in sterile water. No other diluent should be used.

Table 1. TRELSTAR Recommended Dosing

Dosage

3.75 mg

11.25 mg

22.5 mg

Recommended dose

1 injection every
4 weeks

1 injection every
12 weeks

1 injection every
24 weeks

Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule.

The suspension should be administered immediately after reconstitution.

As with other drugs administered by intramuscular injection, the injection site should be alternated periodically.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Reconstitution Instructions for TRELSTAR

Please read the instructions completely before you begin.

Wash your hands with soap and hot water and put on gloves immediately prior to preparing the injection.

Place the vial in a standing upright position on a clean, flat surface that is covered with a sterile pad or cloth.

Remove the Flip-Off® button from the top of the vial, revealing the rubber stopper.

Disinfect the rubber stopper with an alcohol wipe. Discard the alcohol wipe and allow the stopper to dry.

Using a syringe fitted with a sterile 21-gauge needle, withdraw 2 mL sterile water for injection, and inject into the vial.

Shake well to thoroughly disperse particles to obtain a uniform suspension. The suspension will appear milky.

Slowly withdraw the entire contents of the reconstituted suspension into the syringe.

The suspension should be administered immediately after reconstitution.

Inject the patient in either buttock with the contents of the syringe.

Reconstitution Instructions for TRELSTAR with MIXJECT SYSTEM

Please read the instructions completely before you begin.

MIXJECT Preparation

Wash your hands with soap and hot water and put on gloves immediately prior to preparing the injection. Place the sealed tray on a clean, flat surface that is covered with a sterile pad or cloth. Peel the cover away from the tray and remove the MIXJECT components and the TRELSTAR vial. Remove the Flip-Off button from the top of the vial, revealing the rubber stopper. Place the vial in a standing upright position on the prepared surface. Disinfect the rubber stopper with the alcohol wipe. Discard the alcohol wipe and allow the stopper to dry. Proceed to MIXJECT Activation.

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